Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia

Atypical Endometrial Hyperplasia Clinical Trial

Official title:

Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05675787
• Other study ID #: 2022PHB416
• Status: Recruiting
• Phase: Phase 2
• Start date: January 6, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: May 2023
• Source: Peking University People's Hospital
• Contact: WANG JIANLIU, PhD/MD
• Phone: +861088324383
• Email: wangjianliu1203[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore the treatment efficacy of medroxyprogesterone acetate plus atorvastatin in patients with atypical endometrial hyperplasia (AEH) and early endometrial carcinoma (EEC) for conservative treatment.

Description:

After diagnosed of AEH or EEC by hysteroscopy, patients meet the study criteria will be enrolled. The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue was detected by Raman scattering instrument. And Age, height, weight, waistline, blood pressure, basic history of infertility and family cancer will be collected. Blood tests, including fasting blood glucose (FBG), fasting insulin (FINS), blood lipids, sex hormone levels, anti-müllerian hormone (AMH) and renal/liver function tests will be performed before treatment to evacuate their basic conditions. Each subject will receive body fat testing by Inbody 770.

Patients will receive MPA (Medroxyprogesterone acetate) 250-500 mg by mouth daily plus atorvastatin 20mg by mouth daily for at least 3 months. Then hysteroscopy will be used to evaluate the endometrial condition every 3 months, and intra-operative findings will be recorded. Complete response (CR) is defined as the reversion of endometrial atypical hyperplasia to proliferative or secretory endometrium; partial response (PR) is defined as regression to hyperplasia with or without atypic; stable disease (SD) is defined as the persistence of the disease; and progressive disease (PD) is defined as the appearance of higher pathological progression, or myometrial invasion, or extra-uterine metastasis. Continuous therapies will be needed in PR. Patients with PD will be recommended for hysterectomy.

For patients remained SD after 9 months of treatment but refused hysterectomy, a multiple disciplinary discussion would be held for individual case, and alternative treatment would be given. Three months of maintenance treatment will be recommended for patients with CR, and participants will be followed up for at least 1 year.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: October 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years to 45 Years

Eligibility

Inclusion Criteria:

• Have a confirmed pathological diagnosis based upon hysteroscopy: histologically prove AEH or well-differentiated EEC G1 without myometrial invasion: 1. Untreated patients;

2. Patients with persistent lesions after one course (12 weeks) of progesterone therapy; 3. Patients who did not achieve complete remission after 2 courses (24 weeks) of progesterone therapy;

• No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound

• Have a desire for remaining reproductive function or uterus

• Good compliance with adjunctive treatment and follow-up

Exclusion Criteria:

• Hypersensitivity or contradiction for using MPA or atorvastatin

• Pregnancy or potential pregnancy

• Confirmed diagnosis of any cancer in reproductive system

• Already diagnosed with hyperlipidemia and using lipid-lowering drugs

• Acute liver disease or liver tumor (benign or malignant) or renal dysfunction

• Acute severe disease such as stroke or heart infarction or a history of thrombosis disease

• With other factors of reproductive dysfunction;

• Strong request for uterine removal or other conservative treatment

• Smoker (>15 cigarettes a day)

• Drinker (>20 grams a day)

Related Conditions & MeSH terms

• Atypical Endometrial Hyperplasia
• Carcinoma
• Endometrial Carcinoma Stage I
• Endometrial Hyperplasia
• Endometrial Neoplasms
• Hyperplasia

Intervention

Drug:
• Medroxyprogesterone acetate + Atorvastatin
MPA (at a dosage of 250-500 mg/day,) + Atorvastatin (at a dosage of 20 mg/day), by mouth,

Locations

Country	Name	City	State
China	Wang Jianliu	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological cumulative complete response rate;	3 to 4 months: From date of initial therapy until the date of CR or date of hysterectomy,	assessed up to 4 months
Secondary	Pathological cumulative complete response rate;	From 6 to 8 months; From date of initial therapy until the date of CR or date of hysterectomy,	assessed up to 8 months
Secondary	The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion tissue	The lipid content (lipid droplet, cholesterol and triglyceride) in endometrial lesion	assessed up to 4 months
Secondary	Overall complete response rate	Pathological response duration	up to 2 years
Secondary	Pathological response rate classified by different blood lipid level	Pathological response rate classified by different blood lipid level	up to 2 years;
Secondary	Relapse rate	Relapse rate	up to 15 months after the end of treatment
Secondary	Pregnancy rate	Pregnancy rate	up to 15 months after the end of treatment
Secondary	Toxic Side Effect	Toxicity evaluation according to CTCAE 5.0 version.	up to 3 months after the end of treatment